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Polymedco, Inc.

United StatesFDA applicant, unverified

Polymedco, Inc. is a medical device manufacturer, with 29 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) and 4 FDA recalls as of 13 Nov 2026.

Devices
29
FDA recalls
4

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 19
  • FDA GUDID 10

A device listed in two registries counts in both.

Device classes
  • FDA Class II 18
  • FDA Class I 11
FDA recalls
Identifiers
  • DUNS 024798555

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue29

Newest first, rows 1-29 of 29

Search and filter all 29 devices
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Rows 1-29 of 29

Company details

DUNS number
024798555

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2013

    • 12 Feb 2013 Z-1059-2013 Class II Terminated The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam. Submission number: K041297
    • 12 Feb 2013 Z-1060-2013 Class II Terminated The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.

  • 2003

    • 3 Dec 2003 Z-0295-04 Unclassified (pre-2012) Terminated Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications. Distribution: Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide. Submission number: K001009
    • 3 Dec 2003 Z-0296-04 Unclassified (pre-2012) Terminated Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications. Distribution: Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide. Submission number: K001009

Frequently asked questions

How many devices does POLYMEDCO, INC. have in the registry?

The registry currently lists 29 devices for POLYMEDCO, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list POLYMEDCO, INC.'s devices?

Among its 29 most recently registered devices, POLYMEDCO, INC. has devices listed in FDA 510(k) (19 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do POLYMEDCO, INC.'s devices fall under?

Among its 29 most recently registered devices, the classes recorded for POLYMEDCO, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for POLYMEDCO, INC.?

FDA recall records list 4 recalls initiated by POLYMEDCO, INC., the most recent initiated on 12 Feb 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from POLYMEDCO, INC. in the registry?

The most recently registered devices listed for POLYMEDCO, INC. include C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT, PolyTiter ANA-CAL, Poly stat STS25 and Poly stat HCG-POC.

Generated automatically from registry data and not verified by a human reviewer.